MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 1-2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71453101
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a bilateral tka surgery was performed on (b)(6) 2019, the patient exhibited left knee instability, implant loosening, poly space wear, femoral component damage and femoral component debris (suggestive of possible metallosis).After x-rays were taken on (b)(6) 2023, the patient was advised to perform weight management strategies such as dietary adjustments, static cycling and supportive footwear.Further x-rays taken on (b)(6) 2024, revealed indications of implant wear, calcification, and metallosis in the left knee.It was stated on a pet-ct report dated (b)(6) 2024 that the bilateral tkr status was noted with significant streak artefacts around it obscuring the locoregional anatomic details, with diffuse increased fdg uptake around the left knee joint.It is unknown how this adverse event will be treated.The patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, tibial component loosening with insert disassociation is suspected as a likely root cause of the reported events as this would allow for metallic articulation/contact between the tibial baseplate and oxinium femoral component; however, the definitive primary clinical root cause cannot be concluded based on the images provided.The date of symptom onset is unknown but the time between imaging indicates surgical intervention was delayed at least 7 months and therefore contributed to the overall severity of the adverse events.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the devices did not reveal similar events for the listed devices.A review of the instructions for use documents for knee systems reveal in possible adverse effects that wear of the polyethylene articulating surfaces of knee replacement components has been reported following total knee replacement.Higher rates of wear may be initiated by particles of cement, metal, or other debris which can cause abrasion of the articulating surfaces.Higher rates of wear may shorten the useful life of the prosthesis, and lead to early revision surgery to replace the worn prosthetic components.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include joint laxity, patient condition, irregular implant interaction and/or abnormal motion over.Based on this investigation, the need for corrective action is not indicated.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LGN CR HIGH FLEX XLPE SZ 1-2 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19656772
• Report Number: 1020279-2024-01282
• Device Sequence Number: 12383082
• Product Code: JWH
• UDI-Device Identifier: 00885556033432
• UDI-Public: 00885556033432
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71453101
• Device Lot Number: 19BM09558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 09/04/2024
• Date Device Manufactured: 02/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GNS II CMT TIB SIZE 2 {} LEFT, LOT# :19GM21686.; LEGION CR OXIN FEM SZ4 LT, LOT #:19DM22882.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female